Data / Medical devices / United States / Blustone Synergy, LLC
Blustone Synergy, LLC: FDA-registered device maker in Pueblo, CO, United States, 2 510(k) clearances
Blustone Synergy, LLC is registered with the FDA (registration 3014019090) in Pueblo, CO, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014019090
- Address
- 5520 Ventana Ct, Pueblo, CO, United States, 81005
- Owner or operator
- Blustone Synergy, LLC (10055810)
- Roles
- Specification developer
- First device listed
- October 9, 2017
- Registered through
- 2026
- Brand names listed
- Blustone Synergy Baalt Lumbar PLIF Pusher, Blustone Synergy Basalt Lumbar Interbody Fusion System, Blustone Synergy Basalt Lumbar PLIF Inserter, Blustone Synergy Basalt/Magma/Obsidian Lumbar Shaver, Blustone Synergy Basalt/Obsidian/Magma Lumbar Trial/Spreader, Blustone Synergy Magma Lumbar Interbody Fusion System, Blustone Synergy Magma Lumbar Lateral Inserter, Blustone Synergy Obsidian Lumbar Interbody Fusion System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2017 | K172330 | Blustone Synergy Silica System | MQP | Substantially Equivalent | Blustone Synergy | accessdata.fda.gov |
| September 8, 2017 | K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) | MAX | Substantially Equivalent | Bluestone Synergy | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Rasp
- All makers of Guide, Surgical, Instrument
- All makers of Pusher, Socket
- All makers of Instrument, Cutting, Orthopedic
Updated December 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.